Chinese Authorized Representative Service
Medical Device Chinese Agent
The regulations targets are Chinese inland legal entities, so to distribute medical products in China, the foreign companies must set up a subsidiary in China, or designate a Chinese Legal Agent to take up the regulatory responsibilities in China. We can collaborate to serve as your Chinese agent and fulfill the regulatory requirements by NMPA by doing the following work:
- To assist medical device registration process in order to obtain registration certificate.
- To assist registration update and extension (which is only valid for 5 years).
- To keep record of technical materials and post-market data in preparation for inspection of China Medical Device Administration.
- To follow up and investigate the updates of Chinese medical device regulations and give feedback to the manufacturer.
- To work as the contact company between China Medical Device Administration and the manufacturer to ensure smooth communication.
- To communicate with the manufacturer about the Chinese regulations and pathways in a correct and professional way.
- To investigate post-market adverse events and report such event to the manufacturer and NMPA.
- To assist product recall when necessary.
- To assume joint responsibilities related product quality issues and post-market service.
The foreign manufacturer can only designate one company as its Chinese Agent, who should complete all Chinese regulatory affairs including registration, alteration and recall etc.
Medical Device Legal Agent is different from Product Agent. Legal Agent should take up the legal responsibilities required by Medical Device Regulations as the representative of the overseas manufacturer, while a Product Agent should conduct business activities in Chinese market as a trade representative.
Post-Market Compliance-After Sales Service Agent
To distribute foreign medical products in China, the manufacturer has to designate a local Chinese company as After-sales agent. An After Sales Service Agent is responsible for regulatory affairs after the medical device has been listed in the market, helping the manufacturer to avoid regulatory risk to ensure business development in China. The manufacturer can appoint more than one After Sales Service Agents in China. The main responsibilities include the following aspects.
- To handle customer complaints for any quality issues during usage of products, either by replying promptly to such enquiries or sending technical service staff to help the customer solve such problems.
- To pay regular visits to customers and accept quality advices from customs and give feedback to the manufacturer.
- Customs should be informed of any significant changes of the product technologies promptly to ensure smooth communication.
- Any adverse effect should be reported to the authorized agent, and to National Medical Product Administration (NMPA) when necessary.
- To assist the manufacturer for product registration renewal before registration expires (renewal every 5 years).
Third Party Technology Support
We provide Third Party support as authorized by the manufacturer,
- To supervise the manufacturer’s Chinese Agent, After Sales Service Units and distributors as the manufacturer’s local representative.
- To help the manufacturer to contact Chinese National Medical Product Administration (NMPA).
- To make emergency plans and coordinate with the manufacturer to initiate emergency plans.
- To assist the manufacturer to formulate risk management measures before and post market listing and rectification measures when in need.
- To help the manufacturer to collect market data and develop marketing strategies.
